Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology: Intense Dynamic Monitoring of ctDNA in Advanced/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients Treated With Immune Checkpoint Inhibitors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The change in kinetics of ctDNA changes in advanced/metastatic will be measured for HNSCC patients treated with immune checkpoint inhibitors (anti-PD-1 antibody).
研究概览
简要总结
This study aims to study the kinetics of ctDNA levels after the first dose of immune checkpoint inhibitor in patients with recurrent or metastatic head and neck cancer. This is an important study to understand the optimal timing for ctDNA quantitation for future studies in immunotherapy, though further validation would be needed in other tumor types. It may help standardize the most relevant blood collection time points so that patients will not be subjected to multiple blood draws at random time points in future liquid biopsy trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytological confirmed recurrent, metastatic or advanced HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown origin (but being treated as HNSCC).
- •Availability of tumor sample.
- •Patients who are going to receive at least one dose of anti-PD1antibody (nivolumab or pembrolizumab).
排除标准
- •Nasopharynx, maxillary sinus, nasal/nasal vestibule squamous tumors
- •Patients who are receiving concomitantly any other tumor-specific treatment (chemotherapy, radiotherapy, any monoclonal antibodies different from anti- PD-1 antibodies).
结局指标
主要结局
The change in kinetics of ctDNA changes in advanced/metastatic will be measured for HNSCC patients treated with immune checkpoint inhibitors (anti-PD-1 antibody).
时间窗: Through study completion, up to 1.5 years
At each time-point, absolute ctDNA levels will be calculated from all test targets (including undetected targets).The change in ctDNA from baseline to every time-point is defined as the percentage change in absolute ctDNA levels in plasma at that end point since baseline.
次要结局
- The changes in ctDNA levels will be measured. These value will help correlate with progression free survival (PFS) and overall survival (OS).(Through study completion, up to 1.5 years)
- The optimal time-point will be measured to analyze ctDNA as a predictive marker of response to immune checkpoint inhibitors (anti-PD-1 antibody).(Through study completion, up to 1.5 years)